Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Randomized, Double-blind, Placebo-controlled, 2-period, Cross-over Study to Assess the Efficacy and Safety of Differing Doses of NVA237 Administered Either Once Daily or Twice Daily, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

This study was designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD.

Inclusion Criteria:

• Male and female patients age 40 years or more
• Diagnosis of Chronic Obstructive Lung Disease (COPD) (moderate to severe as classified by the Global Initiative for COPD (GOLD) Guidelines, 2008
• Smoking history of at least 10 pack-years
• Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) <80% and ≥30% of the predicted normal value
• Post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.7
• Symptomatic patients, according to daily electronic diary data between visit 2 (Day -8) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to visit 3

Exclusion Criteria:

• Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to the first visit
• Patients who have had a respiratory tract infection within 4 weeks prior to the first visit
• Patients with concomitant pulmonary disease
• Patients with diabetes Type I or uncontrolled diabetes Type II
• Any patient with lung cancer or a history of lung cancer
• Patients with a history of certain cardiovascular co-morbid conditions
• Patients with a history of asthma or a blood eosinophil count >600/mm3 or onset of symptoms prior to 40 years
• Patients with eczema, known high IgE levels or a known positive skin prick test
• Patients participating in the active phase of a pulmonary rehabilitation programme
• Patients contraindicated for the treatment with anticholinergics, long and short-acting beta-2 agonists or sympathomimetic amines
• Patients with a history of alpha-1 anti-trypsin deficiency
• Patients on long term oxygen therapy (>15hr per day)
• Other protocol-defined inclusion/exclusion criteria may apply